Enforcing Permitted Sequences
Ideally, a 21 CFR Part 11 compliant application should be usable for quality assurance in a manufacturing process. To meet this goal, it is necessary that the application support "operational system checks to enforce permitted sequencing of steps and events". In other words, it should be possible for a technician in quality assurance to run the application with minimal input and limited possibility to affect the results through incorrect decisions.
ASTRA and DYNAMICS SP have strong support for enforcing permitted sequences through the methods (known as 'presets' in DYNAMICS). A user with Researcher privilege level can create a new experiment, and then save it as a Method. A user with Technician privilege level can only use the Method to collect and analyze data, and cannot make changes to the Method configuration, analysis, or results reporting.
With their template/preset technology, ASTRA and DYNAMICS support moving macromolecular and nanoparticle characterization into everyday manufacturing and quality assurance applications.